Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00385788
First received: October 9, 2006
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.


Condition Intervention Phase
Hodgkin's Disease
Drug: Gemcitabine
Drug: Fludarabine
Drug: Melphalan
Drug: Antithymocyte Globulin
Procedure: Allogeneic Stem Cell Infusion
Drug: Tacrolimus
Drug: Filgrastim (G-CSF)
Drug: Methotrexate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Participants with Transplant Related Mortality [ Time Frame: Transplant to 100 days post transplant ] [ Designated as safety issue: Yes ]
    Transplant-related mortality defined as death from any cause in the first 100 days post-transplant in patients without active disease.


Estimated Enrollment: 70
Study Start Date: July 2005
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine + Fludarabine + Melphalan
Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes for one day; Fludarabine 33 mg/m^2 IV for 4 days; Melphalan 70 mg/m^2 IV over 30 minutes for 2 days. Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation. If receiving transplant from matched unrelated donor (not blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant, infusion of stem cells on Day 0. Tacrolimus 0.03 mg/kg by vein over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
Drug: Gemcitabine
800 mg/m^2 IV over 30 minutes on Day -7 (1 day)
Other Names:
  • Gemzar
  • Gemcitabine hydrochloride
Drug: Fludarabine
33 mg/m^2 IV over 30 minutes Day -5 to Day -2 (4 days)
Other Names:
  • Fludarabine Phosphate
  • Fludara
Drug: Melphalan
70 mg/m^2 IV over 30 minutes on Day -3 to Day -2 (2 days)
Drug: Antithymocyte Globulin

2 mg/kg IV on Day -4 and Day -3 (2 days) before stem cell transplantation.

If receiving transplant from matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant.

Other Names:
  • ATG
  • Thymoglobulin
Procedure: Allogeneic Stem Cell Infusion
Infusion of stem cells on Day 0.
Other Names:
  • AST
  • Stem Cell Transplantation
  • SCT
Drug: Tacrolimus
0.03 mg/kg beginning Day -2 by vein over 24 hours; when tolerable change to pill form given once daily for 3-4 months.
Other Name: Prograf
Drug: Filgrastim (G-CSF)
Starting 1 week after transplant (Day +7) given as injection under the skin once daily until blood cell levels return to normal.
Other Name: Granul
Drug: Methotrexate
5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD.
Other Name: MTX

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients < 65 years of age with histologically confirmed refractory or relapsed Hodgkin's disease (including patients who fail or relapse after autologous SCT). This upper age limit will apply to transplants from both matched related and unrelated donors.
  2. Patients should have any of the following disease status: a. responsive or stable disease on salvage chemotherapy or radiation therapy. b. untreated, smoldering (i.e. not rapidly progressive) relapses.
  3. Patients must have a serum bilirubin equal to or </=2.0 mg/dl (isolated hyperbilirubinemia related to Gilbert's disease allowed), serum transaminase (ALT) equal to or </= 3 times the upper limit of the normal range, serum creatinine <2.0 mg/dl (provided they also have a glomerular filtration rate of at least 55 ml/min), no symptomatic cardiac or pulmonary disease and a performance status equal to or </=2. Left ventricular ejection fraction >/= 40%, FEV1, FVC and corrected DLCO >/= 50% predicted.
  4. Patients must have an HLA-compatible related or unrelated donor (one-antigen mismatched related donors are acceptable) willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells. In the event of transplants from matched unrelated donors, a high-resolution allele match for HLA-A, -B, -C, -DRB1 ("8 of 8 match") is required.
  5. Women of childbearing potential must have a negative serum pregnancy test within two weeks of study entry and should be advised to avoid becoming pregnant. Men should be advised to not father a child while on treatment. Both women of childbearing potential and men must agree to practice effective methods of contraception.
  6. Patients must be capable and willing to sign informed consent.

Exclusion Criteria:

  1. Patients with documented disease progression on salvage chemotherapy.
  2. Nursing or pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately.
  3. Severe concomitant medical or psychiatric illness.
  4. Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease.
  5. Chronic active hepatitis or cirrhosis.
  6. Active or uncontrolled infection.
  7. Radiation therapy involving chest (axilla excluded), mediastinum, or abdomen (i.e., small or large bowel) completed within 10 weeks of transplant admission. Radiation therapy shortly before the start of the preparative regimen is allowed.
  8. Prior or concurrent malignancies (including myelodysplasia) except resected basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Chair. Cancer treated with curative intent > 5 years previously will be allowed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385788

Contacts
Contact: Paolo Anderlini, MD 713-792-8750

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Paolo Anderlini, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Paolo Anderlini, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00385788     History of Changes
Other Study ID Numbers: 2005-0015, NCI-2012-01376
Study First Received: October 9, 2006
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Hodgkin's Disease
Stem Cell Transplantation
Antithymocyte Globulin
Gemcitabine
Gemzar
Fludarabine
Fludarabine Phosphate
Melphalan
Allogeneic stem cell transplantation
AST
SCT
ATG
Thymoglobulin

Additional relevant MeSH terms:
Hodgkin Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antilymphocyte Serum
Fludarabine
Fludarabine phosphate
Gemcitabine
Melphalan
Methotrexate
Tacrolimus
Vidarabine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antiviral Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors

ClinicalTrials.gov processed this record on October 23, 2014